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Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

NCT04652739 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-12-03

No results posted yet for this study

Summary

The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.

Conditions

  • Erosive Lichen Planus

Interventions

DRUG

Lycopene Softgel, 10 Mg

Patients were given 10 mg of lycopene softgel capsules once daily for two months. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract.

DRUG

Prednisolone

Patients were given 40 mg of prednisolone tablets once daily in the morning for one month, afterwards, the dose was tapered along the following month. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study. The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone).

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Aliaa A Bedeir, BDS · Faculty of Dentistry, Alexandria University, Egypt

  • Azza M Zaki, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Sabah A Mahmoud, PhD · Faculty of Medicine, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-03-03
Completion
2019-03-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652739 on ClinicalTrials.gov